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Human Genome Sciences Announces Albuferon(R) Meets Primary Endpoint in Phase 3 Trial in Chronic Hepatitis C
Date:12/8/2008

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  • North America: 82.5% (85/103) for 900-mcg albinterferon alfa-2b, vs. 81.5% (88/108) for peginterferon alfa-2a;
  • Asia: 79.8% (75/94) for 900-mcg albinterferon alfa-2b, vs. 95.5% (85/89) for peginterferon alfa-2a;
  • Europe: 78.1% (64/82) for 900-mcg albinterferon alfa-2b, vs. 81.7% (67/82) for peginterferon alfa-2a;
  • Other regions: 75.8% (25/33) for 900-mcg albinterferon alfa-2b, vs. 74.2% (23/31) for peginterferon alfa-2a.
  • Patients receiving 900-mcg albinterferon alfa-2b had comparable rates of serious adverse events, severe adverse events, and discontinuations due to adverse events, vs. peginterferon alfa-2a.
  • The incidence of severe and/or serious adverse events was comparable between the two groups, with 17.3% (54/313) in the albinterferon alfa-2b 900-mcg treatment group, vs. 17.5% (54/309) in the peginterferon alfa-2a treatment group.
  • The incidence of severe and/or serious pulmonary adverse events was also comparable between these groups: severe and/or serious pulmonary infections were 0.6% (2/313) for 900-mcg albinterferon alfa-2b, vs. 0.6% (2/309) for peginterferon alfa-2a; and severe and/or serious respiratory, thoracic or mediastinal disorders were 1.0% (3/313) for 900-mcg albinterferon alfa-2b, vs. 1.3% (4/309) for peginterferon alfa-2a.
  • Overall, adverse events observed were those typically associated with interferon therapy, and the rate of discontinuations due to adverse events was comparable: 4.8% (15/313) for 900-mcg albinterferon alfa-2b, vs. 3.6% (11/309) for peginterferon alfa-2a.
  • Treatment Group Originally Randomized to Receive Albinterferon Alfa-2b 1200-mcg Every Two Weeks and Reduced to 900-mcg Following January 2008 Dose Modification, vs. Treatment Group Receiving Peginterferon Alfa-2a 180-mcg Every Week

    Due to the dose modification announced in J
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    SOURCE Human Genome Sciences, Inc.
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